- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02460783
Intermittent Calorie Restriction, Insulin Resistance, and Biomarkers of Brain Function
Background:
- Insulin removes sugar from the blood to use for energy. Insulin resistance means that cells may not respond to insulin normally. It can lead to serious diseases. Researchers want to see how diet affects insulin resistance, weight, and brain chemicals related to Alzheimer s disease.
Objectives:
- To compare two forms of diet and their effects on insulin resistance and the brain.
Eligibility:
- Women ages 55 70 with insulin resistance.
Design:
- This study requires 6 clinic visits over 9 12 weeks. Participants must fast before visits.
- Visit 1, screening:
- Medical history, physical exam, and blood and urine tests.
- Participants will get a wrist device to wear for 4 days.
- Visit 2:
- Weight and waist measurement.
- Blood drawn.
- Questionnaires and thinking tests.
- Lumbar puncture. Skin will be numbed and a needle inserted between bones in the back will remove <TAB>fluid.
- Participants will drink a nutrition shake. Blood will be taken 12 times over 4 <TAB>hours through a thin tube in <TAB>the arm.
- Brain MRI. Participants will lie on a table that slides in and out of a cylinder in a strong magnetic field. <TAB>They will have a coil on their head and may do tasks.
- Participants will get advice about healthy eating and be randomly put in one of 2 groups. One group will get <TAB>nutrition shakes to drink.
- Visits 3 5:
- Weight and waist measurements, vital signs, blood draw, and questionnaires.
- Between visits, participants will get a call or email to check how they are doing.
- Visit 6: Repeat of visit 1.
- Participants will wear the wrist device for 4 more days, have a follow-up contact, then the study is finished.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21224
- National Institute of Aging, Clinical Research Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
- INCLUSION CRITERIA:
- BMI greater than or equal to 27; in addition, weight less than or equal to 350 lbs (weight limit for MRI scanner);
- Age of 55-70 years;
- HOMA-IR greater than or equal to 1.8;
- MMSE greater than or equal to 26
EXCLUSION CRITEIRA:
- History of clinically significant cardiovascular disease for the purpose of this study, such as chronic heart failure, coronary disease, cardiomyopathy, clinically significant cardiac valvular disease or clinically significant peripheral vascular disease. Cardiovascular conditions that are clinically non-significant for the purpose of this study, such as controlled hypertension, minor EKG abnormalities, mitral valve prolapse or benign murmurs are permissible;
- History of clinically significant stroke or other neurological disease of the central nervous system;
- History of substance abuse in the past 6 months or positive urine drug screen;
- History of clinically significant endocrine disorders (common mild endocrine disorders, such as untreated subclinical hypothyroidism with TSH < 10 mU/l or successfully treated hypothyroidism may be allowed);
- History of eating disorders, significant GI disorders or malabsorption disorders;
- History of type 2 diabetes; and/or use of anti-diabetes medications or insulin; and/or type 2 diabetes diagnosed during the screening visit based on fasting glucose > 125 mg/dL;
- History of hypoglycemia; and/or a fasting glucose < 70 mg/dL during the screening visit.
- Current use of systemic corticosteroids;
- Positive screening tests for HIV, HCV or HBV;
- Hematocrit less than 35% or hemoglobin less than 11 mg/dL;
- ALT or AST > 1.5 times the upper normal limit;
- Contraindications for MRI (pacemakers, ferrous metal implants or shrapnel in or around the head, etc.).
- Contraindications to LP, such as Coumadin, coagulopathy (international normalized ratio, or INR > 1.5; prothrombin time (PT), partial prothrombin time (PTT) > 1.5 x upper normal limit). Aspirin 81 mg qd is allowed. Aspirin up to 325 mg qd is allowed, if withheld for 7 days prior to the LP.
- Pregnancy or nursing.
- Refusal to consent to genetic testing for APOE.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Healthy Living Diet
Healthy living diet for 7 days/week
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Counseling and educational material on diet portion, consistency
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Experimental: 5-2 CR
Healthy living diet for 5 days/week; Calorie Restriction (480 Kcal in the form of a shake) for 2 days/week.
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Regular diet for 5 days/week; Calorie Restriction (480 Kcal in the form of a shake) for 2 days/week.
Supplement providing 240 Kcal per shake.
Participant takes 2 shakes per calorie restriction day.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated Serine312-insulin Receptor Substrate-1 (pS312-IRS-1)
Time Frame: Week 0, Week 4, Week 8
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IRS-1 is an intracellular adaptor molecule that is being recruited and activated by the binding of insulin and insulin-like growth factor to their respective receptors and in insulin resistance (IR) it shows aberrant phosphorylation in serine residues resulting in impaired downstream signal propagation.
pS312-IRS-1 is considered an index of brain insulin resistance and a therapeutic response biomarker for interventions targeting brain IR.
A decrease in its levels indicates target engagement with the intervention and improvement in brain IR.
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Week 0, Week 4, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) P-pan-Tyrosine-IRS-1 (pY-IRS-1)
Time Frame: Week 0, Week 4, Week 8
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IRS-1 is an intracellular adaptor molecule that is being recruited and activated by the binding of insulin and insulin-like growth factor to their respective receptors and in insulin resistance (IR) it shows aberrant phosphorylation in tyrosine residues resulting in impaired downstream signal propagation.
pY-IRS-1 is considered an index of brain insulin resistance and a therapeutic response biomarker for interventions targeting brain IR.
A decrease in its levels indicates target engagement with the intervention and improvement in brain IR.
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Week 0, Week 4, Week 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change in Body Weight
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Body Mass Index (BMI)
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Waist Circumference
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Fasting Glucose
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Fasting Insulin
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Homeostatic Model Assessment of Insulin Resistance 2 (HOMA2-IR)
Time Frame: Week 0, Week 8
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Homeostatic Model Assessment of Insulin Resistance Index 2 (HOMA2-IR) is a marker of peripheral insulin resistance and is calculated by fasting insulin (μIU/L) multiplied by fasting glucose (mg/dL), and divided by a constant (405).
A higher score indicates higher insulin resistance.
A cut-off of 1.8 was used to indicate peripheral insulin resistance.
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Week 0, Week 8
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Mean Change in Glycosylated Hemoglobin (HbA1c)
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in White Blood Cells (WBCs)
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Red Blood Cells (RBCs)
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Platelets
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Hemoglobin
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Hematocrit
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in International Normalized Ratio (INR)
Time Frame: Week 0, Week 8
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The International Normalized Ratio (INR) is derived from prothrombin time (PT) which is calculated as a ratio of the patient's PT to a control PT standardized for the potency of the thromboplastin reagent developed by the World Health Organization (WHO) using the following formula: INR = Patient PT ÷ Control PT.
The higher the INR, the longer it takes for blood to clot.
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Week 0, Week 8
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Mean Change in Serum Beta-Hydroxybutyrate (bHB)
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Serum Acetoacetate (AcAc)
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Serum Non-Esterified Fatty Acids (NEFA)
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Serum Cortisol
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Creatinine
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Blood Urea Nitrogen (BUN)
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Alanine Aminotransferase (ALT)
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Aspartate Aminotransferase (AST)
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Total Cholesterol
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in HDL Cholesterol
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in LDL Cholesterol
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Triglycerides
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Cerebrospinal Fluid (CSF) Amyloid Beta 42
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Cerebrospinal Fluid (CSF) Amyloid Beta 40
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Cerebrospinal Fluid (CSF) Amyloid Beta 42 / Amyloid Beta 40 Ratio
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Cerebrospinal Fluid (CSF) Total Tau
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Cerebrospinal Fluid (CSF) p181-Tau
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Cerebrospinal Fluid (CSF) Neurogranin
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Cerebrospinal Fluid (CSF) Light Chain Neurofilaments (Nf-L)
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Cerebrospinal Fluid (CSF) Glial Fibrillary Acidic Protein (GFAP)
Time Frame: Week 0, Week 8
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Week 0, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Amyloid Beta 42
Time Frame: Week 0, Week 4, Week 8
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Week 0, Week 4, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Amyloid Beta 40
Time Frame: Week 0, Week 4, Week 8
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Week 0, Week 4, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Amyloid Beta 42 / Amyloid Beta 40 Ratio
Time Frame: Week 0, Week 4, Week 8
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Week 0, Week 4, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Total Tau
Time Frame: Week 0, Week 4, Week 8
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Week 0, Week 4, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) p181-Tau
Time Frame: Week 0, Week 4, Week 8
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Week 0, Week 4, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) p231-Tau
Time Frame: Week 0, Week 4, Week 8
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Week 0, Week 4, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Akt
Time Frame: Week 0, Week 4, Week 8
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Akt (or protein kinase B) is an insulin signaling cascade mediator.
An increase in its levels indicates an improvement in brain insulin resistance.
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Week 0, Week 4, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated Serine473-Akt (pS473-Akt)
Time Frame: Week 0, Week 4, Week 8
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pS473-Akt is an insulin signaling cascade mediator.
An increase in its levels indicates activation of downstream insulin signaling pathway.
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Week 0, Week 4, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated Serine473-Akt (pS473-Akt) / Akt Ratio
Time Frame: Week 0, Week 4, Week 8
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Week 0, Week 4, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated Extracellular Signal-regulated Kinase 1/2 (pERK1/2)
Time Frame: Week 0, Week 4, Week 8
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pERK1/2 is an insulin signaling cascade mediator.
An increase in its levels indicates activation of downstream insulin signaling pathway.
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Week 0, Week 4, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated c-Jun N-terminal Kinase (pJNK)
Time Frame: Week 0, Week 4, Week 8
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JNK is an insulin signaling cascade mediator.
Activated JNK (pJNK) inhibits insulin signaling.
An increase in pJNK levels indicates inhibition of downstream insulin signaling pathway.
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Week 0, Week 4, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated p38 (pp38)
Time Frame: Week 0, Week 4, Week 8
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p38 is an insulin signaling cascade mediator.
Activated p38 (pp38) inhibits insulin signaling.
An increase in pp38 levels indicates inhibition of downstream insulin signaling pathway.
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Week 0, Week 4, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) proBDNF
Time Frame: Week 0, Week 4, Week 8
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Week 0, Week 4, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) BDNF
Time Frame: Week 0, Week 4, Week 8
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Week 0, Week 4, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Neurogranin
Time Frame: Week 0, Week 4, Week 8
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Week 0, Week 4, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Heavy Chain Neurofilaments (Nf-H)
Time Frame: Week 0, Week 4, Week 8
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Week 0, Week 4, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) A-synuclein
Time Frame: Week 0, Week 4, Week 8
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Week 0, Week 4, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) TAR DNA-binding Protein 43 (TDP-43)
Time Frame: Week 0, Week 4, Week 8
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Week 0, Week 4, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Monocarboxylate Transporter 1 (MCT1)
Time Frame: Week 0, Week 4, Week 8
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Week 0, Week 4, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Monocarboxylate Transporter 2 (MCT2)
Time Frame: Week 0, Week 4, Week 8
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Week 0, Week 4, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Mitochondrial Complex IV Quantity
Time Frame: Week 0, Week 4, Week 8
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Complex IV is part of the mitochondrial electron transport chain.
Decreased complex IV levels in NDEVs have been found in patients with Alzheimer's disease.
A decrease in its levels may indicate decreased ability of neurons for ATP production and energy crisis.
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Week 0, Week 4, Week 8
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Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Mitochondrial Complex V Quantity
Time Frame: Week 0, Week 4, Week 8
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Complex V is part of the mitochondrial electron transport chain.
Decreased complex V levels in NDEVs have been found in patients with Alzheimer's disease.
A decrease in its levels may indicate decreased ability of neurons for ATP production and energy crisis.
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Week 0, Week 4, Week 8
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Mean Change in Glucose by Proton J-PRESS MRS of Posteromedial Cortex (PMC)
Time Frame: Week 0, Week 8
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Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glucose concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra.
Glucose relative ratio to creatine was quantified.
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Week 0, Week 8
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Mean Change in N-acetyl-aspartate by Proton J-PRESS MRS of Posteromedial Cortex (PMC)
Time Frame: Week 0, Week 8
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Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) N-acetyl-aspartate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra.
N-acetyl-aspartate relative ratio to creatine was quantified.
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Week 0, Week 8
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Mean Change in Lactate by Proton J-PRESS MRS of Posteromedial Cortex (PMC)
Time Frame: Week 0, Week 8
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Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Lactate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra.
Lactate relative ratio to creatine was quantified.
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Week 0, Week 8
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Mean Change in Glutamate by Proton J-PRESS MRS of Posteromedial Cortex (PMC)
Time Frame: Week 0, Week 8
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Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutamate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra.
Glutamate relative ratio to creatine was quantified.
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Week 0, Week 8
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Mean Change in Gamma-Aminobutyric Acid (GABA) by Proton J-PRESS MRS of Posteromedial Cortex (PMC)
Time Frame: Week 0, Week 8
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Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Gamma-Aminobutyric Acid (GABA) concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra.
Gamma-Aminobutyric Acid (GABA) relative ratio to creatine was quantified.
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Week 0, Week 8
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Mean Change in Glutamine by Proton J-PRESS MRS of Posteromedial Cortex (PMC)
Time Frame: Week 0, Week 8
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Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutamine concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra.
Glutamine relative ratio to creatine was quantified.
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Week 0, Week 8
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Mean Change in Glutathione by Proton J-PRESS MRS of Posteromedial Cortex (PMC)
Time Frame: Week 0, Week 8
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Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutathione concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra.
Glutathione relative ratio to creatine was quantified.
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Week 0, Week 8
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Mean Change in Myo-Inositol by Proton J-PRESS MRS of Posteromedial Cortex (PMC)
Time Frame: Week 0, Week 8
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Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Myo-Inositol concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra.
Myo-Inositol relative ratio to creatine was quantified.
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Week 0, Week 8
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Mean Change in N-acetyl-aspartyl-glutamate by Proton J-PRESS MRS of Posteromedial Cortex (PMC)
Time Frame: Week 0, Week 8
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Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) N-acetyl-aspartyl-glutamate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra.
N-acetyl-aspartyl-glutamate relative ratio to creatine was quantified.
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Week 0, Week 8
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Mean Change in Ascorbate by Proton J-PRESS MRS of Posteromedial Cortex (PMC)
Time Frame: Week 0, Week 8
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Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Ascorbate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra.
Ascorbate relative ratio to creatine was quantified.
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Week 0, Week 8
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Mean Change in Alanine by Proton J-PRESS MRS of Posteromedial Cortex (PMC)
Time Frame: Week 0, Week 8
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Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Alanine concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra.
Alanine relative ratio to creatine was quantified.
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Week 0, Week 8
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Mean Change in Scyllo-Inositol by Proton J-PRESS MRS of Posteromedial Cortex (PMC)
Time Frame: Week 0, Week 8
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Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Scyllo-Inositol concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra.
Scyllo-Inositol relative ratio to creatine was quantified.
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Week 0, Week 8
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Mean Change in Glucose by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC)
Time Frame: Week 0, Week 8
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Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glucose concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra.
Glucose relative ratio to creatine was quantified.
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Week 0, Week 8
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Mean Change in Lactate by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC)
Time Frame: Week 0, Week 8
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Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Lactate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra.
Lactate relative ratio to creatine was quantified.
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Week 0, Week 8
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Mean Change in Glutamate by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC)
Time Frame: Week 0, Week 8
|
Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutamate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra.
Glutamate relative ratio to creatine was quantified.
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Week 0, Week 8
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Mean Change in Glutamine by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC)
Time Frame: Week 0, Week 8
|
Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutamine concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra.
Glutamine relative ratio to creatine was quantified.
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Week 0, Week 8
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Mean Change in Glutathione by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC)
Time Frame: Week 0, Week 8
|
Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutathione concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra.
Glutathione relative ratio to creatine was quantified.
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Week 0, Week 8
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Mean Change in Myo-Inositol by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC)
Time Frame: Week 0, Week 8
|
Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Myo-Inositol concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra.
Myo-Inositol relative ratio to creatine was quantified.
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Week 0, Week 8
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Mean Change in N-acetyl-aspartyl-glutamate by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC)
Time Frame: Week 0, Week 8
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Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) N-acetyl-aspartyl-glutamate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra.
N-acetyl-aspartyl-glutamate relative ratio to creatine was quantified.
|
Week 0, Week 8
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Mean Change in Ascorbate by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC)
Time Frame: Week 0, Week 8
|
Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Ascorbate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra.
Ascorbate relative ratio to creatine was quantified.
|
Week 0, Week 8
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Mean Change in Alanine by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC)
Time Frame: Week 0, Week 8
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Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Alanine concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra.
Alanine relative ratio to creatine was quantified.
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Week 0, Week 8
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Mean Change in Scyllo-Inositol by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC)
Time Frame: Week 0, Week 8
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Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) glucose concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra.
Glucose relative ratio to creatine was quantified.
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Week 0, Week 8
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Mean Change in Executive Function Composite
Time Frame: Week 0, Week 8
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Executive function was assessed with the National Institutes of Health (NIH) Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER) battery that comprises written, verbal, and computerized tasks that test working memory, inhibition, set shifting, fluency, planning, insight, and social cognition and behavior.
The Executive function Composite is a computerized score calculated based on the individual tests.
It ranges between 0 and 10.
Higher score values indicate better performance.
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Week 0, Week 8
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Mean Change in California Verbal Learning Test (CVLT)
Time Frame: Week 0, Week 8
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California Verbal Learning Test (CVLT) assesses verbal memory for unstructured information.
Examinees are asked to recall words on a 16-item list after each of 5 learning trials (Immediate Free Recall; range 0-80 [5 x 0-16]).
After a distractor list, participants are again asked to recall words spontaneously (Short Delay Free Recall; range 0-16) and with category cueing (Short Delay Cued Recall; range 0-16).
Spontaneous recall (Long Delay Free Recall; range 0-16) and category cueing (Long Delay Cued Recall; range 0-16) are repeated after a 20-minute delay.
Following the longer delay, participants also complete a yes/no recognition trial during which they need to discriminate between the target words and 32 distractor words (Long Delay Recognition; range 0-48 [0-16 true positive target words + 0-32 true negative distractor words]).
Higher scores indicate better performance.
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Week 0, Week 8
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Mean Change in Logical Memory (LM) Test
Time Frame: Week 0, Week 8
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Logical Memory (LM) test assesses verbal memory for structured information.
It consists of two thematically independent narrative stories.
Each story has 25 items, which the examinee has to recall with as much detail and precision as possible.
Each item is scored the same regardless of importance level, and all correct items are summed giving a maximum score of 25 for each story.
"Verbatim recall" score only includes the items that are recalled exactly and with detailed information, whereas "gist recall" score includes both the verbatim recall and the items that are recalled with only the essential elements of the information.
The examinee has to recall the two stories twice, immediately after their initial administration (immediate recall) and after a 20 to 30-minute delay (delayed recall).
Total maximum score for each of the subtests is 50 (25 items x 2 stories) and the minimum score is 0. Higher scores indicate better performance.
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Week 0, Week 8
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Change in the Positive and Negative Affect Schedule (PANAS)
Time Frame: Week 0, Week 8
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Positive and Negative Affect Schedule (PANAS) is a 20-item self-report measure to assess positive and negative affect and is an index of emotional state.
For positive affect, score can range from 10 - 50, with higher scores representing higher levels of positive affect.
For negative affect, score can range from 10 - 50, with lower scores representing lower levels of negative affect.
|
Week 0, Week 8
|
Mean Change in the Short Form 36-item Health Survey (SF-36)
Time Frame: Week 0, Week 8
|
Short Form 36-item Health Survey (SF-36) is a gauge of physical and psychosocial effects of the interventions.
It consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability; the higher the score the less disability.
|
Week 0, Week 8
|
Mean Change in Total Energy Expenditure
Time Frame: Week 0, Week 8
|
Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions.
|
Week 0, Week 8
|
Mean Change in Daily Energy Expenditure
Time Frame: Week 0, Week 8
|
Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions.
|
Week 0, Week 8
|
Mean Change in Hourly Energy Expenditure
Time Frame: Week 0, Week 8
|
Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions.
|
Week 0, Week 8
|
Mean Change in Metabolic Rate
Time Frame: Week 0, Week 8
|
Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions.
|
Week 0, Week 8
|
Mean Change in Time in Activity
Time Frame: Week 0, Week 8
|
Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions.
|
Week 0, Week 8
|
Mean Change in Total Steps
Time Frame: Week 0, Week 8
|
Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions.
|
Week 0, Week 8
|
Mean Change in Steps Per Minute
Time Frame: Week 0, Week 8
|
Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions.
|
Week 0, Week 8
|
Mean Change in Total Sedentary Bouts
Time Frame: Week 0, Week 8
|
Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions.
|
Week 0, Week 8
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dimitrios I Kapogiannis, M.D., National Institute on Aging (NIA)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 150123
- 15-AG-0123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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